ChondroCelect
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, surgeon or physical therapist.
If you get any of the side effects, talk to your doctor, surgeon or physical therapist. This includes any possible side effects not listed in this leaflet. See section 4.
What ChondroCelect is and what it is used for
What you need to know before you use ChondroCelect
How to use ChondroCelect
Possible side effects
How to store ChondroCelect
Contents of the pack and other information
Medicinal product no longer authorised
ChondroCelect consists of autologous cultured cartilage cells. The product is made from a small sample of cartilage cells (a biopsy) taken from your knee.
ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults. A defect can be caused by acute trauma, such as a fall. It can also be caused by repetitive trauma, as a result of overweight or due to incorrect weight-bearing on the knee as a result of a knee deformity.
The femoral condyle is the end of the thigh bone, which forms part of your knee.
are allergic to any of the ingredients of ChondroCelect (listed in section 6) or to bovine serum
suffer from advanced osteoarthritis (degenerative joint disease) in your knee.
have a growth plate of the knee that is not fully closed
Talk to your doctor, surgeon or physiotherapist before using ChondroCelect.
If you have an acute or recent history of bone or joint infections, you should be temporary deferred until documented recovery.
The use of ChondroCelect is generally not recommended when you are overweight (i.e. a Body Mass Index over 30) because it could compromise the result of the treatment. Your surgeon will give you more information.
ChondroCelect is not recommended for the repair of cartilage defects in other locations than the femoral condyle.
ChondroCelect should be implanted in an otherwise healthy knee. This means that other knee problems such as lesions of the knee ligament or of the meniscus should be corrected before or during ChondroCelect implantation.
You should resume physical activity according to the rehabilitation plan recommended by the physical therapist. Too early and vigorous activity may compromise the implant and the durability of clinical benefit from ChondroCelect.
Other cases in which ChondroCelect cannot be supplied
Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the product, it is possible that you will not be eligible for treatment with ChondroCelect. This is the case if the biopsy is of insufficient quality to make ChondroCelect, or in some instances, it may be the cells cannot be grown in the laboratory or that the cells after expansion do not meet all the quality requirements Your surgeon will be informed and might have to select an alternative treatment for you.
The use of ChondroCelect is not recommended in children and adolescents below 18 years.
Medicinal product no longer authorised
Please tell your doctor or physical therapist if you are taking, have recently taken or might take any other medicines.
The safe use of ChondroCelect with other medicines has not been studied.
Ask your doctor for more information as to which pain medication you can safely use.
The safe use of ChondroCelect has not been demonstrated during pregnancy or breast-feeding. ChondroCelect is not recommended for pregnant and breast-feeding women.
Please inform your doctor if you are pregnant or think you may be pregnant.
The surgical procedure will have a major influence on your ability to drive and use machines. Driving cars and using machines may be limited during the rehabilitation period, and the advice of your doctor, surgeon or physical therapist should be strictly followed during this period.
ChondroCelect can only be prescribed and implanted by an orthopaedic surgeon in a hospital. Treatment with ChondroCelect: a two-step procedure.
On the first visit, the surgeon will evaluate your cartilage defect during an exploratory operation (arthroscopy). An arthroscopy is performed through very small incisions in the skin, using a narrow telescope (arthroscope) to look at the inside of the knee. If the surgeon decides that treatment with ChondroCelect is appropriate for you, he/she will take a small sample of cartilage cells (a biopsy) from your knee. This cartilage sample will be used to make ChondroCelect.
It will take at least four weeks to select and culture the cells to make ChondroCelect.
During open-knee surgery, the cartilage cells are implanted into the cartilage defect. This is called ‘autologous chondrocyte implantation’ (ACI). The purpose is to repair the defect with healthy and functional cartilage over time.
To keep the cartilage cells in place, a biological membrane is sewn over the defect.
After surgery, you will have to follow a rehabilitation program for approximately one year, to allow your knee to heal well. Your doctor or physical therapist will give you more details on your rehabilitation.
You should be very cautious when bending and putting weight on your treated knee. During the rehabilitation period, the level of weight-bearing will increase gradually, depending on your weight and the size of the cartilage defect. To protect your knee, you will have to wear a brace.
If you have any further questions on the use of this medicine, ask your doctor or physical therapist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Medicinal product no longer authorised
Most side effects of ChondroCelect implantation are side effects related to open-knee surgery. In general, these side effects are quite mild and disappear in the weeks following surgery.
You can recognize most of the joint- related side effects if you have symptoms like pain, snapping, grinding, locking, swelling, bending limitations and stiffness in the knee. Tell your doctor immediately if you notice any of these symptoms.
If you get any side effects, talk to your doctor or physical therapist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container and vial after EXP. Store between 15°C – 25°C.
Do not refrigerate or freeze.
Keep the product vial(s) within the falcon tube in the plastic screw top container in order to protect from light and bacterial/fungal contamination.
Do not irradiate.
Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal
Medicinal product no longer authorised
The active substance of ChondroCelect consists of a treatment dose of viable autologous human cartilage cells in vials containing 4 million cells in 0.4 ml, corresponding to a concentration of 10,000 cells/microlitre.
The other ingredient is sterile, buffered Dulbecco’s Modified Eagles Medium (DMEM), a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial.
ChondroCelect is a cell suspension (a fluid) for implantation. The cells are kept alive in a small sterile
vial. The product is packaged in several layers of packaging material which guarantee sterility and stable temperature conditions for 48 hours if stored at room temperature.
Each pack contains an individual treatment dose consisting of 1 to 3 vials, depending on the number of cells needed to treat the specific lesion size.
Marketing Authorisation Holder: TiGenix N.V.
Romeinse straat 12/2, 3001 LEUVEN Belgium
+32 16 39 60 60
+32 16 39 60 70
Manufacturer:
PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, Netherlands
Medicinal product no longer authorised
Medicinal product no longer authorised
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of ChondroCelect remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Only 907 patients have been exposed up to now, including patients treated with ChondroCelect within the clinical trials conducted to support the MA of ChondroCelect. Post-marketing experience with respect to patient number, i.e. 444 patients and duration of follow-up is still quite limited, and doesn’t warrant granting a renewal with unlimited validity.
The CHMP decided that the MAH should continue to submit 1-yearly PSURs.
Medicinal product no longer authorised
Therefore, based upon the safety profile of ChondroCelect, which requires the submission of 1- yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years’ time.